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NCT03681223 · ClinicalTrials.gov registry record · NA

Restorelle® Y Mesh vs. Vertessa® Lite Y Mesh for Laparoscopic and Robotic-assisted Laparoscopic Sacrocolpopexy

A NA study, sponsored by The Cleveland Clinic.

Completed
Registry status
NA
Development phase
106
Enrollment target

NCT03681223: Completed NA study, sponsored by The Cleveland Clinic.

NCT03681223 is a NA study that has completed, run by The Cleveland Clinic. The registered enrollment target is 106 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03681223, a NA study, has completed, sponsored by The Cleveland Clinic.

COMPLETED
Registry status
NA
Development phase
106 participants
Enrollment target

Study Summary

This is a randomized clinical trial to compare outcomes between the Restorelle® Y mesh and Vertessa® lite Y mesh for the treatment of vaginal vault prolapse. Hypothesis: Vertessa® lite Y mesh is not inferior to Restorelle® Y mesh for the treatment of vaginal vault prolapse

Primary Outcome

Retreatment for prolapse by either surgery or pessary

Interventions

  • DEVICE Vertessa® Lite Y mesh
  • DEVICE Restorelle® Y mesh
  • PROCEDURE Laparoscopic sacrocolpopexy
  • PROCEDURE Robotic assisted laparoscopic sacrocolpopexy

Trial Details

FieldValue
Enrollment Target 106 participants
Start Date 2018-09-18
Est. Completion 2023-12-19
Phase NA
The Cleveland Clinic

688 total trials

What the finished NCT03681223 record still lists

NCT03681223 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 4 interventions - of which Vertessa® Lite Y mesh is the first listed.

NCT03681223 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03681223 about?

NCT03681223 is a clinical study titled "Restorelle® Y Mesh vs. Vertessa® Lite Y Mesh for Laparoscopic and Robotic-assisted Laparoscopic Sacrocolpopexy". This is a randomized clinical trial to compare outcomes between the Restorelle® Y mesh and Vertessa® lite Y mesh for the treatment of vaginal vault prolapse. Hypothesis: Vertessa® lite Y mesh is not inferior to Restorelle® Y mesh for the treatment of vaginal vault prolapse

What is the current status of trial NCT03681223?

This trial is currently completed. It is a NA study. The enrollment target is 106 participants. The study started on 2018-09-18. Estimated completion is 2023-12-19.

What interventions are being tested in trial NCT03681223?

The interventions under investigation include: Vertessa® Lite Y mesh (DEVICE), Restorelle® Y mesh (DEVICE), Laparoscopic sacrocolpopexy (PROCEDURE), Robotic assisted laparoscopic sacrocolpopexy (PROCEDURE).

Who is sponsoring clinical trial NCT03681223?

This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03681223's enrollment target sits among peer trials

106 830th of 2000 higher than 1,167 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03681223, the US trial registry maintained by the National Library of Medicine. NCT03681223 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.